Dapoxetine

New Drug Application Submitted for Dapoxetine for Premature Ejaculation

MOUNTAIN VIEW, Calif., December 28, 2004 -- ALZA Corporation today announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for dapoxetine hydrochloride, a new treatment for premature ejaculation (PE). Premature ejaculation is the most common male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives.

"Premature ejaculation is a frequent and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners," says James H. Barada, M.D., urologist at the Center for Male Sexual Health, Albany, NY, and board member of the Sexual Medicine Society of North America (SMSNA).

If approved by the FDA, dapoxetine hydrochloride would be the first prescription treatment designed specifically to treat PE and will be marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc.

ALZA Corporation, headquartered in Mountain View, California, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable, and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA's drug delivery technologies.

Ortho-McNeil Pharmaceutical, Inc. markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology and migraine headaches.

For more information, please visit the Ortho-McNeil Pharmaceutical website at www.ortho-mcneil.com or ALZA's website at www.alza.com.

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ALZA Corporation Receives Letter From FDA on Dapoxetine Application - October 26, 2005

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